Fri, June 01, 2012
China > Mainland

SFDA plans to blacklist drug makers

2012-06-01 02:14:56 GMT2012-06-01 10:14:56(Beijing Time)  Global Times

China's food and drug safety watchdog has invited public consultation on a proposal to blacklist drug manufacturers with shady reputations - a "name and shame" policy experts have hailed as necessary to restore public confidence in the wake of a tainted capsule scandal.

The State Food and Drug Administration (SFDA) published the draft on its website Wednesday.

The proposed blacklist would expose drug manufacturers' names on government websites, which would restrict them from bidding on future projects, according to the SFDA proposal.

Ending up on the blacklist would also undermine manufacturers' ability to secure bank loans.

Wang Lianglan, an SFDA spokeswoman, was quoted by the Xinhua News Agency as saying that the blacklist would also include individuals banned from the drug business for over 10 years by law.

"The blacklist would help provide better transparency for the public," Wang said. "It would also help regulate the country's pharmaceutical industry."

If the draft is approved, eight categories of individuals and companies would be blacklisted, including those who produce or sell fake drugs, produce medical instruments without a business license and cause injuries with their unlicensed products.

The SFDA added that the officials would closely supervise manufacturers on the list and require them to periodically report on their quality management.

He Jiguo, a senior analyst for the China National Center for Food Safety Assessment, told the Global Times that the blacklist is critical for restoring public confidence in the country's pharmaceutical industry following a recent tainted capsule scandal.

"The poisonous capsule scandal tarnished the reputation of the country's pharmaceutical industry and fueled patient mistrust in domestically-made medicines," he said.

"Such a blacklist would provide authoritative guidelines for consumers when they make purchases in the future."

He added that the food and drug safety watchdog could even consider more aggressive regulatory measures.

"A drug manufacturer blacklist will persuade companies to follow safety regulations," he said. "A ban on drug production should be applied to violators."

The reputation of the country's drug manufacturing industry plunged to an all-time low after the government detained 45 people and seized more than 77 million capsules tainted with chromium in April.

A monthlong inspection launched by the SFDA found that 254 pharmaceutical companies, or 12.7 percent of the country's capsule drug producers, contained high levels of chromium.

The Ministry of Public Security said in a statement released in late April that it had shut down 80 illegal production lines in Zhejiang, Hebei and Jiangxi provinces after a joint investigation with the SFDA.

While there have been no reports of deaths or sickness caused by the contaminated capsules, the SFDA said long-term exposure to chromium could cause serious damage to organs.

The weeklong public consultation on the draft regulation to blacklist drug manufacturers will begin tomorrow.

The public can leave messages on the SFDA website to voice their opinions.

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